Comparing two methods of labour induction in term pregnant women who had one previous Caesarean delivery and history of vaginal birth(s)

Induction of labour in one previous Caesarean delivery and history of vaginal birth(s) with Foley catheter versus controlled-release dinoprostone vaginal insert: a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15310448

Enrollment

Registered

2021-08-19

Start date

2021-08-23

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour induction Pregnancy and Childbirth

Interventions

This study is a randomised trial to compare Foley catheter with controlled-release dinoprostone vaginal Insert for induction of labour in women with one previous caesarean delivery and history of vagi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Scheduled induction of labour 2. One previous scar 3. History of vaginal birth(s) 4. Aged 18 years and above 5. Gestational age of >37 weeks at enrolment 6. Unfavorable cervix (Bishop Score <6) 7. Singleton pregnancy 8. Cephalic presentation 9. Reassuring pre-induction fetal cardiotocography (CTG) 10. Intact membranes 11. Absence of significant contraction =2 in 10 minutes

Exclusion criteria

Exclusion criteria: 1. Preference for elective repeated caesarean section 2. Allergic to latex 3. Allergic to prostaglandin 4. Inability to give consent 5. Known gross fetal anomaly 6. Absolute contraindication to vaginal delivery 7. Estimated fetal weight of <2 kg or =4 kg

Design outcomes

Primary

Measure	Time frame
Caesarean section rate collected from patients’ medical records after the patient has delivered and measured after the completed sample size for this study	—

Secondary

Measure	Time frame
Maternal outcomes: 1. Use of additional method for cervical ripening, taken from patients’ medical records after delivery 2. Bishop score upon first assessment upon removal of induction of labor method 3. Spontaneous rupture of membrane or amniotomy, taken from patients’ medical records after delivery 4. Use of oxytocin for intrapartum augmentation, taken from patients’ medical records after delivery 5. Duration of oxytocin use, taken from patients’ medical records after delivery 6. Type of analgesia in labor, taken from patients’ medical records after delivery 7. Estimated blood loss for delivery, taken from patients’ medical records after delivery 8. Fever =38°C, taken from patients’ medical records and collected from initiation of induction of labour until patient discharge 9. Complications (scar rupture, blood transfusion, maternal admission to ICU/HDU, hysterectomy, re-laparotomy, others), taken from patients’ medical records during induction of labour, intrapartum and postpartum until patient discharge 10. Uterine hyperstimulation syndrome, taken from patients’ medical records from first 24 hours from initiation of induction of labour and obtained after delivery 11. Terbutaline use, taken from patients’ medical records after delivery 12. Maternal satisfaction with induction method using a visual numerical rating scale (scored from 0 to 10), obtained upon removal/dislodge of the induction device 13. Pain during the insertion of the device, measured using the visual analogue score (VAS) as soon as possible after placement of induction device Neonatal outcomes: 1. APGAR score at 1 and 5 minutes, measured using the APGAR score scoring system after delivery 2. Arterial cord pH, taken from arterial cord blood gas and obtained after delivery 3. Birth weight, taken from patients’ medical records after delivery 4. Neonatal admission and indication, taken from patients’ medical records after delivery 5. Neonatal complications, taken from patients’ medical records after	—

Measure

Time frame

Maternal outcomes: 1. Use of additional method for cervical ripening, taken from patients’ medical records after delivery 2. Bishop score upon first assessment upon removal of induction of labor method 3. Spontaneous rupture of membrane or amniotomy, taken from patients’ medical records after delivery 4. Use of oxytocin for intrapartum augmentation, taken from patients’ medical records after delivery 5. Duration of oxytocin use, taken from patients’ medical records after delivery 6. Type of analgesia in labor, taken from patients’ medical records after delivery 7. Estimated blood loss for delivery, taken from patients’ medical records after delivery 8. Fever =38°C, taken from patients’ medical records and collected from initiation of induction of labour until patient discharge 9. Complications (scar rupture, blood transfusion, maternal admission to ICU/HDU, hysterectomy, re-laparotomy, others), taken from patients’ medical records during induction of labour, intrapartum and postpartum until patient discharge 10. Uterine hyperstimulation syndrome, taken from patients’ medical records from first 24 hours from initiation of induction of labour and obtained after delivery 11. Terbutaline use, taken from patients’ medical records after delivery 12. Maternal satisfaction with induction method using a visual numerical rating scale (scored from 0 to 10), obtained upon removal/dislodge of the induction device 13. Pain during the insertion of the device, measured using the visual analogue score (VAS) as soon as possible after placement of induction device Neonatal outcomes: 1. APGAR score at 1 and 5 minutes, measured using the APGAR score scoring system after delivery 2. Arterial cord pH, taken from arterial cord blood gas and obtained after delivery 3. Birth weight, taken from patients’ medical records after delivery 4. Neonatal admission and indication, taken from patients’ medical records after delivery 5. Neonatal complications, taken from patients’ medical records after

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026